Sugemalimab Approved to Treat Adult Patients with Non-Small Cell Lung Cancer
London, 30 October 2024 – The Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 with a Combined Positive Score (CPS) of ≥1%.
Sugemalimab is a monoclonal antibody that blocks the PD-1 receptor on T cells, thereby restoring their ability to recognize and attack cancer cells. It is the first PD-1 inhibitor to be approved for the treatment of NSCLC in the UK.
The approval is based on the results of the Phase III KEYNOTE-189 trial, which showed that sugemalimab improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in patients with advanced NSCLC. In the trial, the median OS was 13.8 months for patients treated with sugemalimab compared to 10.9 months for patients treated with chemotherapy. The median PFS was 6.8 months for patients treated with sugemalimab compared to 4.9 months for patients treated with chemotherapy.
Sugemalimab is generally well tolerated, with the most common side effects being fatigue, diarrhoea, nausea, and rash.
The approval of sugemalimab is a significant advance in the treatment of NSCLC. It is the first PD-1 inhibitor to be approved for the treatment of this type of cancer, and it has shown promising results in clinical trials. Sugemalimab is a welcome addition to the treatment options available for patients with NSCLC.
About the MHRA
The MHRA is the UK’s independent regulator of medicines and medical devices. The MHRA’s mission is to protect and promote public health by ensuring the safety, quality, and effectiveness of medicines and medical devices.
About sugemalimab
Sugemalimab is a humanised monoclonal antibody that binds to the PD-1 receptor on T cells. PD-1 is a negative regulator of T cell activation, and by blocking PD-1, sugemalimab restores the ability of T cells to recognise and attack cancer cells.
Sugemalimab is approved for the treatment of adult patients with locally advanced or metastatic NSCLC whose tumours express PD-L1 with a CPS of ≥1%.
About non-small cell lung cancer
NSCLC is the most common type of lung cancer, accounting for about 80% of all cases. It is a cancer that begins in the cells that line the airways and air sacs in the lungs.
NSCLC is a serious disease, and the 5-year survival rate for patients with advanced NSCLC is only about 15%. However, new treatments, such as sugemalimab, are improving the outlook for patients with this type of cancer.
Sugemalimab approved to treat adult patients with non-small cell lung cancer
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